Dissecting Aneurysm of Cerebral ArteryATREAT-VBDNCT04943783
Atorvastatin in the TREATment of Intracranial Unruptured VertebroBasilar Dissecting Aneurysms
A study testing Atorvastatin 20mg in people with Dissecting Aneurysm of Cerebral Artery and Intramural Hematomas, run by Beijing Neurosurgical Institute at 2 sites in China.
Trial summary
This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissecting Aneurysm of Cerebral Artery, Intramural Hematomas, Inflammation Vascular
- What is being tested?
- Atorvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2021to 30 Jul 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18 or over, male or non-pregnant female;
- Patients have a unruptured vertebrobasilar dissecting aneurysm identified on imaging (CT, MRI or DSA)
- Patients with wall enhancement and intramural hematomas of UVBDAs by HR-VW-MRI before treatment.
- Patients who is able to understand the objective of the trail, agrees and signs the written informed consent form.
Who cannot join
- The aneurysm types of non-dissecting aneurysm, such as saccular aneurysms, fusiform aneurysms and traumatic aneurysms, etc.;
- Patients with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;
- Planned treatment of the aneurysm within 6 months;
- Several impaired liver or renal functions;
- Retreatment of recurrent aneurysm;
- Pregnant or lactating women;
- Patients with malignant diseases, such as liver disease, kidney diseases, congestive heart failure, malignant tumors, etc.;
- Poor compliance patients;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yisen Zhang, MD, +86-010-59978852, zhang-yisen@163.com
Mirzat Turhon, MD, +86-18699158800, 18699158800@163.com
- Not yet recruiting
Mirzat Turhon
Beijing
Mirzat Turhon, MD, +86-010-59978852, 18699158800@163.com
About this study
Official title: Application of Atorvastatin in the TREATment of Patients With Intracranial Unruptured Vertebrobasilar Dissecting Aneurysms
This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin.
Read the detailed description
Unruptured vertebrobasilar dissecting aneurysms (UVBDAs) are a pathological condition of the vertebrobasilar artery caused by hypertension, atherosclerosis, and infection. Hematoma between intima and media can progressively occlude the parent artery. Thus lead to decreasing perfusion of the distal perforator vessels and even cause cerebral infarction. Even worse, ruptured VBDAs can lead to subarachnoid hemorrhage and eventually death of the patients. Thus, risk of UVBDAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making.
Recently, many histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of aneurysms. High-resolution vessel wall MRI (HR-VW-MRI) has been increasingly applied in clinical practice and is the only noninvasive method for imaging the structure of the vascular wall.
Wall enhancement of an aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial aneurysm. Besides, a previous study has demonstrated that HR-MRI can provide valuable information, such as parameters of intramural hematomas, double lumens and intimal flaps, in the diagnosis and follow-up UVBDAs.
Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are widely used cholesterol-lowering drugs and are established as first-line treatments for hypercholesterolemia. In addition, statins exert pleiotropic effects to protect the vasculature. Statins can reduce the inflammation of the vessel wall and mobilize endothelial progenitor cells for aneurysmal endothelial cell repair. Statins can also inhibit the expression of several matrix metalloproteinases by smooth muscle cells and macrophages, which may be important in reducing the growth and rupture of UVBDAs.
In this study, participants with UVBDAs that are not planned for surgical treatment and has not yet ruptured, take atorvastatin daily for six months, and have a HRMRI scan before and after conservative therapy to look for the role of atorvastatin in inflammation.
- Being tested
- Atorvastatin 20mg
- Keywords
- High resolution magnetic resonance, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
One with the intervention (Atorvastatin, 20mg OD), 20 patients for this arm.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin, 20mg once a day, for six months Receives: Drug: Atorvastatin 20mg |
| No drug | No intervention | no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.
Measured: 6 months
Secondary outcomes (3)
Change of aneurysmal morphology parameter （the largest diamater）
Change of aneurysmal morphology parameter between pre-treatment and the 6 months follow-up periods.
Measured: 6 months
Change of wall features of UVBDAs
Change of wall features of UVBDAs, which is intramural hematoma between pre-treatment and the 6 months follow-up periods. (The maximum diameter of the false lumen was compared)
Measured: 6 months
Change of inflammatory markers in UVBDAs patients
Change of inflammatory markers in UVBDAs patients between pre-treatment and the 6 months follow-up periods. (CRP, TNF alpha, IL-2,6,8,10 and IL-1 beta)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dissecting Aneurysm of Cerebral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943783
- Sponsor's protocol ID
- BNI-20210601
- Acronym
- ATREAT-VBD
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available on reasonable request.
Publications
Zhang Y, Wang C, Dong L, Turhon M, Kang H, Liu J, Duan Y, Tian D, Sui B, Zhang Y, Wang K, Mossa-Basha M, Yang X, Zhu C. Statins Reduce Wall Enhancement at Vessel Wall MRI in Unruptured Vertebrobasilar Dissecting Aneurysms: A Randomized Controlled Trial. Radiology. 2025 Dec;317(3):e242806. doi: 10.1148/radiol.242806.
PubMed 41432563Turhon M, Kang H, Huang J, Li M, Liu J, Zhang Y, Wang K, Yang X, Zhang Y. Atorvastatin for unruptured intracranial vertebrobasilar dissecting aneurysm (ATREAT-VBD): protocol for a randomised, double-blind, blank-controlled trial. BMJ Open. 2022 Apr 28;12(4):e059616. doi: 10.1136/bmjopen-2021-059616.
PubMed 35487525